The present invention relates to a medical site connection for use in medical applications and more particularly, to a connector for forming a connection to a needleless injection site, which may include an elastomeric valve body having a thin diaphragm with a diametrically extending slit. A method of providing such a connection is also provided.
There is a recognized need for eliminating needles for use with injection sites in order to avoid the disadvantages therewith including the possibility of medical personnel receiving a puncture wound and the progressive deterioration of the diaphragm resulting from repetitive puncturing of the diaphragm.
As discussed in the background of U.S. Pat. No. 5,533,708, there have been several proposed solutions to fulfill this need. One proposed solution for eliminating needles at coupling sites includes providing a valve member having a slit for receiving a blunt cannula therethrough wherein the slit is biased to a closed position such that a fluid-tight seal is formed at the valve member when the cannula is removed.
Both the American National Standards Institute, Inc. (ANSI) and the International Organization for Standardization (ISO) have recognized standard dimensions for both male and female luer taper fittings. Thus, the fittings formed on the ends of syringes, as well as fittings for the majority of fluid connections used in medical applications throughout the world, conform to the ANSI and ISO standards.
Additional considerations involved with needleless injection sites include certain physical design limitations associated with a valve element which will both receive a luer taper as well as reliably reseal after the luer taper is removed. Several prior art valves for receiving a luer taper provide a thick disk or septum, such as is disclosed in U.S. Pat. No. 5,135,489, wherein the disk or septum is formed with a sufficient amount of resilient material around the slit to close the slit when a cannula is not present. Space must be provided in order to accommodate the distortion of material around the slit as the cannula is inserted and this space must either be provided within the fluid passage area for receiving the cannula or within the housing supporting the disk or septum, such as may be provided by an annular space directly adjacent to the outer periphery of the disk or septum.
Alternatively, the slit may be formed in a relatively thin diaphragm, such as is disclosed in U.S. Pat. No. 4,765,588 to Atkinson, wherein sufficient space for receiving the distorted portions of the diaphragm around the slit is provided within a space defined by the tubular body portion for receiving the luer taper. Additional improvements to providing a medical coupling site having a relatively thin diaphragm are also found in U.S. Pat. No. 5,533,708 to Atkinson.
As there are many design constraints associated with connecting medical devices, such as syringe luer locks, and needleless injection sites, a connector adapting the medical device to the injection site may be desirable to provide an improved coupling site connection.
Accordingly, there is a need for an improved medical fluid path coupling site connection for attaching a needleless injection site to a medical device, such as on a standard syringe.